11069239 (B.P.A.I. Jan. 20, 2012)

Ex Parte Maskin

Board of Patent Appeals and InterferencesJan 20, 2012

11069239 (B.P.A.I. Jan. 20, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 11/069,239 03/01/2005 Steven Maskin MAS 100 8791 23579 7590 01/23/2012 Pabst Patent Group LLP 1545 PEACHTREE STREET NE SUITE 320 ATLANTA, GA 30309 EXAMINER DRISCOLL, LORA E BARNHART ART UNIT PAPER NUMBER 1653 MAIL DATE DELIVERY MODE 01/23/2012 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte STEVEN MASKIN __________ Appeal 2010-010293 Application 11/069,239 Technology Center 1600 __________ Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and FRANCISCO C. PRATS, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2010-010293 Application 11/069,239 2 STATEMENT OF CASE The following claim is representative. 26. A method of lubricating the eye of a patient in need thereof, consisting of applying a composition consisting essentially of an effective amount of an emulsion of a jojoba wax and an aqueous solution to lubricate the eye surface, wherein the jojoba wax is selected from the group consisting of jojoba wax, components of jojoba wax, and derivatives of jojoba wax, wherein the jojoba wax emulsion optionally contains a second emollient, wherein the ratio of the jojoba to the optional second emollient is from greater than 1:5 to 500:1. Cited References Mitchell US 4,588,717 May 13, 1986 Glonek et al. US 4,914,088 Apr. 3, 1990 Chandrasekaran et al US 5,188,826 Feb. 23, 1993 Korb et al. US 5,371,108 Dec. 6, 1994 Yanni et al. US 5,696,166 Dec. 9, 1997 Tsubota US 6,043,213 Mar. 28, 2000 Grounds of Rejection 1. Claims 2, 4, 13, and 25-27 are rejected under 35 U.S.C. § 112 second paragraph for indefiniteness. 2. Claims 2, 4, 26, and 27 are rejection under 35 U.S.C. § 103(a) over Glonke in view of Korb, Yanni, and Mitchell. 3. Claims 13 and 25 are rejection under 35 U.S.C. § 103(a) over Glonek in view of Korb, Yanni, Mitchell, Chandrasekaran, and Tsubota. FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Answer at pages 4-18. Appeal 2010-010293 Application 11/069,239 3 Discussion 1. Claims 2, 4, 13, and 25-27 are rejected under 35 U.S.C. § 112 second paragraph for indefiniteness. ISSUE With respect to claim 26, the Examiner finds the phrase “’greater than 1:5’” to be indefinite. With respect to claim 13, the Examiner finds that the phrase “’the lubricant or viscosity enhancer’” has no antecedent basis in the claim. (Ans. 4.) Appellant argues with respect to claim 26, that the phrase would be understood by one of ordinary skill in the art to mean that the amount of jojoba wax in the first emulsion as compared to the amount in the “second emulsion is from a low of more than 20% (i.e., greater than 1:5) of the total amount of emulsifier to a high of 99.8% (500:1) of the total amount of emollient.” (App. Br. 11.) The issue is: Are the phrases in the claims indicated by the Examiner indefinite? ANALYSIS With respect to claim 26, we are persuaded by Appellant’s argument and the indefiniteness rejection is reversed. The Examiner has failed to indicate why Appellant’s argument is unconvincing. Appellant does not provide argument with respect to claim 13, and therefore the indefiniteness rejection is maintained for claim 13. Appeal 2010-010293 Application 11/069,239 4 2. Claims 2, 4, 26, and 27 are rejection under 35 U.S.C. § 103(a) over Glonke in view of Korb, Yanni, and Mitchell. 3. Claims 13 and 25 are rejection under 35 U.S.C. § 103(a) over Glonek in view of Korb, Yanni, Mitchell, Chandrasekaran, and Tsubota. ISSUE The Examiner concludes that A person of ordinary skill in the art would have had a reasonable expectation of success in substituting the jojoba wax of Korb for the phospholipid of Glonek because Korb specifically teaches that compositions comprising jojoba wax are useful for treating dry eye and because Yanni teaches that compositions comprising hydroxyeicosatetraenoic acid, which is chemically similar to a key component of jojoba wax, are useful in treating dry eye. Therefore, at the time of the invention, the person of ordinary skill in the art would have concluded that the phospholipid of Glonek and the jojoba wax of Korb (both of which are hydrophobic) are functional equivalents for each other in the dry eye treatment art and would have been motivated to substitute one for the other. (Ans. 6.) Appellant argues that the Declarations evidence a long standing but unmet need to treat dry eye with the claimed product and the failure of other products to meet this need. (App. Br. 9.) The issue is: Does the cited prior art support the Examiner’s rejection of the claims for obviousness? Does the Declaration evidence rebut the Examiner’s prima facie case of obviousness? Appeal 2010-010293 Application 11/069,239 5 PRINCIPLES OF LAW “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). In order to determine whether a prima facie case of obviousness has been established, we consider the factors set forth in Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the relevant art; and (4) objective evidence of nonobviousness, if present. “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[L]ong-felt need is analyzed as of the date of an articulated identified problem and evidence of efforts to solve that problem.” Texas Instruments, Inc. v. U.S. International Trade Comm., 988 F.2d 1165, 1178 (Fed. Cir. 1993). Although the Court has held that need, prior failure, and commercial success may, “in a close case, tip the scales in favor of patentability.” Goodyear Tire & Rubber Co., Inc. v. Ray-O- Vac Co., 321 U.S. 275, 279, 64 S.Ct. 593, 88 L.Ed. 721 (1944), it has consistently and repeatedly rejected the claim that the standard of invention or nonobviousness can be satisfied solely by these “objective” criteria. Anderson's-Black Rock, Inc., supra at 61, 90 S.Ct. 305; Great Atlantic & Pacific Tea Co., supra, at 340 U.S. at 153, 71 S.Ct 127; Jungersen v. Ostby & Barton Co., 335 U.S., 560, 567, 69 S.Ct. 269, 93 L.Ed. 235 (1949). Appeal 2010-010293 Application 11/069,239 6 Roanwell Corp. v. Plantronics, Inc., 429 U.S. 1004, 1008-1009 (1976). Nevertheless, although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion. Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988). Instead, evidence of secondary considerations are a part of the “totality of the evidence” that is used to reach the ultimate conclusion of obviousness. Kansas Jack, Inc. v. Kuhn, 719 F.2d 1144, 1151 (Fed. Cir. 1983). The weight of secondary considerations may be insufficient to override a determination of obviousness based on primary considerations. Ryko Mfg. Co. v. Nu-Star, Inc, 950 F.2d 714, 719 (Fed. Cir. 1991). For example, a long-felt need must not have been satisfied by another before the invention by applicant. Newell, 864 F.2d at 768 (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved.”). Moreover, weak secondary considerations generally do not overcome a strong prima facie case of obviousness. See Media Techs. Licensing, LLC v. Upper Deck Co., 596 F.3d 1334 [93 USPQ2d 1911] (Fed. Cir. 2010), cert. denied, ---U.S. ---, 131 S.Ct. 305, 178 L.Ed. 144 (2010) (“Even if [the patentee] could establish the required nexus, a highly successful product alone would not overcome the strong showing of obviousness.”); Leapfrog Enters., 485 F.3d at 1162 (holding that the objective considerations of nonobviousness presented, including substantial evidence of commercial success, praise, and long-felt need, were inadequate to overcome a strong showing of primary considerations that rendered the claims at issue invalid). Western Union Co. v. MoneyGram Payment Systems, Inc., 626 F.3d 1361, 1373 (Fed. Cir. 2010). Appeal 2010-010293 Application 11/069,239 7 ANALYSIS We agree with the Examiner’s fact finding, statement of the rejection and responses to Appellant’s arguments as set forth in the Answer. We provide the following additional comment. The evidence of record supports that it was well known in the art at the time of the invention to administer treatments for dry eye in the form of an aqueous emulsion. For example, Glonek discloses that a composition for the treatment may be in the form of an emulsion, preferably in the form of an aqueous emulsion. Glonek, col. 3, ll. 20-32. Korb further evidences that it was well known to use an emulsion to treat dry eye. Korb states that preferably compositions for the treatment of dry eye are in the form of a metastable emulsion or colloid because rapid differentiation of an emulsion and formation of a film over the corneal surface is desirable. Korb, col. 1, ll. 17-19; col. 7, ll. 43-62 and col. 8, ll. 14-16. The prior art further evidences that it was well known to use jojoba wax/oil to treat dry eye. Korb, col. 6, ll. 9-10; col. 10, l. 57. While jojoba oil is suggested in Korb to be less preferred, it is still indicated to be an acceptable oil for the treatment of dry eye. Thus, it would have been prima facie obvious in view of the art to use jojoba oil in the form of an aqueous emulsion for the treatment of dry eye. Appellant contends that “Korb does not disclose an emulsion of any sort, much less of jojoba.” (App. Br. 17.) Appellant also contends that Korb uses jojoba with a solvent and that the film only sustained less than one hour (id. at 19). These arguments are not persuasive. As indicated above, both Glonek and Korb described dry eye treatments with emulsions, providing a Appeal 2010-010293 Application 11/069,239 8 reason to have formulated jojoba as an emulsion. See also Answer 5, 6, 11 13, and 15. Thus, we turn to the question of whether Appellant’s evidence of long-felt need is sufficient to rebut the Examiner’s prima facie case of obviousness. Although we have considered Appellant’s evidence anew, for the reasons given by the Examiner in the Answer at pages 15-17, we are not persuaded that the evidence overcomes the strong showing of obviousness in this case. “[L]ong-felt need is analyzed as of the date of an articulated identified problem and evidence of efforts to solve that problem.” Texas Instruments, Inc. v. International Trade Comm., 988 F.2d at 1178. Appellant’s Declaration evidence fails to indicate the composition of the other dry eye compositions tested and fails to provide an objective criteria indicating suitability or lack of suitability to the user. While Appellant indicated at the oral hearing that at least two of the compositions tested in the Declarations were emulsions, the record itself does not provide this information or the exact compositions of the emulsions tested. Thus, Appellant has not provided clear evidence of failed prior efforts to solve the problem of dry eye consistent with a long-felt need analysis. Thus, we agree with the Examiner that the Declarations merely identify prior art compositions by their tradenames and thus are not clear what the composition of the substances are being compared. (Ans. 15.) For example, it is unclear whether any of the tested substances include jojoba wax/oil. Furthermore, the Examiner indicates that the basis for the Declaration statement regarding the insufficiency of prior art aqueous emulsions is unclear. The Declaration provides no objective criteria for this assessment Appeal 2010-010293 Application 11/069,239 9 or comparison. 1 We do not discount that Appellant may have met a long-felt need in the art, we only indicate that the data of record does not sufficiently establish long-felt need and the insufficiency of a prior art product to meet this need. On balance, on the evidence before us, the weight of secondary considerations is insufficient to override a determination of obviousness based on primary considerations. The obviousness rejection is affirmed. CONCLUSION OF LAW The cited references support the Examiner’s obviousness rejections 2 and 3, which are not overcome by the Declaration evidence. The indefiniteness rejection of claim 26 is reversed and the indefiniteness rejection of claim 13 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED cdc 1 For examples of objective criteria see break-up time, visual blur and lipid thickness tested in Glonek, col. 9, or rating of the tear film in Korb, col. 10.